1. Field of the Invention
The invention herein relates to CNS (central nervous system) stimulants. More particularly, it relates to methods of administering CNS stimulant compounds to humans.
2. Description of the Prior Art
Caffeine (1,3,7-trimethylxanthine) is well known as a CNS stimulant; Olin (ed.), Drug Facts and Comparisons, ch. 6, pp. 1116-1118 (1994) and is found in many common beverages; Olin, supra, p. 1116; Caro et al., in American Pharmaceutical Association (APhA), Handbook of Nonprescription Drugs, Ch. 16, pp. 364-367 (8th Edn.: 1986). It is also available as an over-the-counter (OTC) oral medication in tablet and capsule form; Olin et al., supra, p. 1118; Caro et al., supra, p. 370.
There have also been several other forms of administration of caffeine described or used. Under a physician's prescription caffeine is available in percutaneous injectable form; Olin et al., supra, p. 1118. Elixirs, gels, drops (with caffeine in suspension) and syrups are mentioned in U.S. Pat. No. 4,778,810. U.S. Pat. No. 5,219,858 describes delivery of serotonin antagonist compositions intended for use in drug withdrawal therapy which contain CNS stimulants, and which may be delivered "via any of the accepted modes of administration for therapeutic agents." Both of the aforesaid patents mention possible transmucosal administration. U.S. Pat. No. 4,963,367 provides an exhaustive list of administrable compounds, including "caffeine-sodium benzoate" in injectable form. No reference mentions or suggests any form of spray administration other than conventional nasal sprays.
Unfortunately however, the known methods of administering caffeine in the form of tablets or capsules are not necessarily acceptable to most people and certainly do not lend themselves readily to convenient use. Most people, for instance, will not carry bottles of tablets, pills, syrups or elixirs with them and be observed taking such products when stimulation is needed. Further, in many instances CNS stimulation is needed when it is simply not possible to take a pill, swallow a spoonful of syrup, etc.; e.g., while driving a car or truck. In addition many people, especially the elderly, cannot swallow pills or tablets. When self-administration methods are inconvenient, few people will bother with administering the material.
Some prior art methods are impractical in other than a medical setting. Percutaneous, parenteral, rectal, transdermal and subcutaneous administration of caffeine are all essentially medical administration procedures, not realistically suitable for self-administration, and certainly not suitable for administration in informal and social settings. Inhalant nasal sprays, although providing some transmucosal administration, are not acceptable for administration of caffeine, since large quantities of the sprayed composition also enter the pulmonary system, and there is a serious risk of interference with proper respiration. Further, use of products such as elixirs, syrups and nasal sprays does not provide for metered administration of caffeine.
Many prior art methods do not provide for stimulation in a rapid manner. In many cases (such as the previously mentioned driving of a vehicle) the user cannot wait for an extended period for the caffeine's stimulatory effect to occur; stimulation is needed promptly. The full caffeine component of a tablet or capsule cannot be transferred through the intestinal walls and assimilated into the central nervous system until the capsule or tablet has completely dissolved in the stomach and intestines. Thus, especially in the most common practical prior art self-administration methods, caffeine only slowly reaches the central nervous system and even then the accumulation of the entire dosage of caffeine in the central nervous system requires a prolonged period of time, which in turn means that the stimulatory effect of the caffeine on the person occurs only slowly.
In view of these problems with the prior art administration methods, caffeine usage is significantly less than it would be if people could easily and discreetly self-administer caffeine when appropriate stimulation is needed and without concern about the social setting, using a method which would provide for rapid stimulatory effect. The present invention provides the ability to accomplish just that.